modulation of immunity-related gene expression under the chinese herbal formula ss-1 treatment for sjögren's syndrome

Conditions: Sjögren's Syndrome

Summary: to evaluate the modulation of immunity-related gene expression for the sjögren's syndrome under chinese herbal medicine (ss-1) treatment.

objective: to evaluate the modulation of immunity-related gene expression for the sjögren's syndrome under chinese herbal medicine (ss-1) treatment. method: the evidence of the regulation of oxidative-related cytokines and the antioxidant capacity could be provided from the previous randomized, double-blinded, placebo-controlled, cross-over design, two-center clinical trial for evaluating the effect of chinese herbal medicine (ss-1) for the sjögren's syndrome patients. however, the clinical trail could not find out the modulation of immunity-related gene expression for ss-1 treatment, and it did set up a healthy control group for ss-1 comparison. this study want to establish a healthy control group for evaluating the normal range of oxidative stress and cytokines, which this work could be used to compare with the 72 ss-1 subjects in previous study. and this study also want to analyze the 770 immunity-related gene expression for the sjögren's syndrome under the ss-1 treatment: (1) the best 20 (at least) efficacy sjs subjects who were evaluated before and after ss-1 treatments. (2) the 10 (at least) healthy control subjects. the findings could provide the evidence on the modulation of immunity-related gene expression for clinical manifestation, oxidative stress and cytokine in sjögren's syndrome patients. expected results: 1. establish the normal range of oxidative stress and cytokines for healthy control group. 2. to evaluate the regulatory effect on oxidative stress and cytokine secretion between ss-1 group and healthy control group. 3. to evaluate the immunity-related gene expression for the sjögren's syndrome under the ss-1 treatment. 4. to evaluate the immunity-related gene expression among the best efficacy sjs subjects and healthy control subjects. 5. to evaluate the immunity-related gene expression with the characteristic of tcm tongue diagnosis. 6. to analyze the correlation among clinical manifestations, sjögren's syndrome -related clinical questionnaires and immunity-related gene expression.

Eligibility criteria:
inclusion criteria: * primary or secondary sjögren's syndrome patient * age from 20 to 75 year old, male or female patient * fit the criteria of 2002 year american-european classification * if the subject took cyclosporine, cevimeline, pilocarpine, rituximab or other biological agent before enter into our study, the subject need to stop these drugs for one month * if the subject took gan-lu-yin, sang- ju-yin or xuefu-zhuyu-decoction before enter into our study, the subject need to stop these drugs for one month * secondary sjögren's syndrome patient: * stable treatment: steroid (≦10mg/d) and fixed hydroxychloroquine dose before 3 months enrolled * no abnormal change of immunology, liver, kidney, and blood function * no major life threatened condition exclusion criteria: * alcohol abuse, dm (glucose pc\>200mg/dl) and major life threatened condition * pregnancy or breast feeding * abnormal liver and kidney function * forbid steroid pulse therapy before 3 months enrolled into our study, and forbid the chinese herbal medicine except ss-1

Keywords: sjögren's syndrome gan-lu-yin sang-ju-yin xuefu-zhuyu-decoction oxidative stress immune regulation gene modulation ss-1